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Rectal CancerPhase 2NCT06057831

PET/MRI in Rectal Cancer

A Phase 2 study testing Total Neo-adjuvant Therapy and 18FDG-PET/MRI scan in people with Rectal Cancer, run by AHS Cancer Control Alberta.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to see which participants have a better treatment response using PET/MRI imaging to study the removed tumor, after they have received a total neoadjuvant therapy (TNT). The treatment choice of long course chemo-radiotherapy treatment will be determined by institutional policy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Total Neo-adjuvant Therapy and 18FDG-PET/MRI scan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
May 2027to Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically proven adenocarcinoma of the rectum.
  • Clinical stage 2-3 rectal adenocarcinoma, cT3/4N0/M0 or Tx N1-2/M0, within 16 cm from anal verge (lesion below the sacral promontory).
  • Patients deemed suitable to undergo TNT followed by surgical resection.
  • Male or female ≥ 18 years of age.
  • ECOG/Zubrod status 0-2.
  • Able and willing to follow instructions and comply with the protocol.
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  • Provide written informed consent prior to participation in the study.
  • Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening if there is concern about pregnancy. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal.
  • If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, concerned about pregnancy are not eligible for the study.
  • Females must not be breastfeeding (during treatment and at least 6 months from the last dose).
  • Male patients should agree that not donate sperm during the study (during treatment and at least 6 months from the last dose).
  • Patients of childbearing/reproductive potential should use highly effective birth control methods if indicated, as defined by the investigator, up to the period of finishing adjuvant chemotherapy. A highly effective method of birth control is defined as those that result in low failure rate (i.e., less than 1% per year) when used consistently and correctly.
  • Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.

Who cannot join

  • Patient receiving short course radiotherapy alone for rectal cancer.
  • Patient receiving standard TNT.
  • Patients with metastatic disease.
  • Prior pelvic radiotherapy or chemotherapy.
  • Patients in whom MRI is contra-indicated as per prevailing institutional guidelines (e.g. pacemakers, aneurysm clips, cochlear implant, implanted cardiac defibrillator).
  • Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years.
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  • Inability to lay in supine position for approximately one hour.
  • Nursing or pregnant females.
  • Age <18 years.
  • Previous and concurrent, experimental, chemotherapy, or radiotherapy treatment for primary rectal carcinoma.
  • Patients with malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal (GI) function.
  • Patients with a known history of documented upper GI bleeding or upper GI ulcerative disease.
  • Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.
  • Known current alcohol abuse.
  • Patients with symptomatic inflammatory bowel disease.
  • Patients with uncontrolled hypothyroidism.
  • Patients with chronic liver disease.
  • Patients known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.
  • Any contra-indications for intravenous contrast.
  • History of anaphylactic reaction to medications or drug allergy.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kurian Joseph contact

780-432-8755

kurian.joseph@ahs.ca

About this study

Official title: 18FDG-PET/MRI Imaging in Predicting Pathological Response to Total Neo-adjuvant Therapy in Rectal Cancer

The purpose of this study is to see which participants have a better treatment response using PET/MRI imaging to study the removed tumor, after they have received a total neoadjuvant therapy (TNT). The treatment choice of long course chemo-radiotherapy treatment will be determined by institutional policy.

The researchers will also be looking at whether this study could significantly improve the future management and quality of life of rectal cancer patients.

Conditions
Rectal Cancer
Being tested
Total Neo-adjuvant Therapy, 18FDG-PET/MRI scan
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Neo-adjuvant TherapyRadiation

    • TNT incorporates chemotherapy with concurrent chemoradiotherapy (CRT) in any order.
    • Radiotherapy includes 5000 cGy/25 fractions over 5 weeks.
    • Chemotherapy regimen for Concurrent CRT: Capecitabine
    • Chemotherapy regimens used with TNT are: FOLFIRINOX x 6 cycles, 8-9 courses FOLFOX or 5-6 courses of CAPEOX delivered over 4-6 months.
    • The chemotherapy regimen or the order of treatment will be decided at the discretion of the patient's medical oncologist

  • 18FDG-PET/MRI scanOther

    18FDG-PET/MRI scan within 4 weeks of commencing chemo-radiation and within 1 - 2 weeks before radical rectal cancer surgery.

Study groups in NCT06057831
Study groupRoleWhat they receive
Single ArmExperimentalAll patients receive total neo-adjuvant therapy (TNT), depending on institutional policy
Receives: Radiation: Total Neo-adjuvant Therapy; Other: 18FDG-PET/MRI scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint of the study is pathological response (pCR) prediction with PET/MRI.

    A 3-point scale will be used on PET/MRI assessment. When PET and MRI are concordant, the score remains unchanged. When MRI or PET are discordant, but one modality is definitive for complete response (e.g., MRI showing low intensity crescent at site of tumor or no uptake is identified on corresponding location on PET), a tumor regression grade (TRG) score of 1 will be assigned.

    Measured: Week 29 - Week 31

  2. Correlation between PET/MRI reported pCR and complete(pCR) or incomplete response(non-pCR) to total neoadjuvant therapy determined by final pathology will be defined.

    The pathologic response to the total neo-adjuvant therapy will be assessed generally using classification of tumor regression grade (TRG) defined by Mandard et al.

    Measured: Week 31

Secondary outcomes (2)

  1. To evaluate the significance of PET/MRI compared to MRI to predict response to TNT.

    MRI imaging performed before and after TNT and the post TNT scans will be compared to baseline to identify the degree of regression. This comparison to baseline imaging will be performed to avoid misinterpretation of pseudotumor (inflammatory changes within normal rectal wall adjacent to regressed tumor) as residual tumor.

    Measured: Week 29 - Week 31 (1 - 2 weeks before surgery)

  2. A feasibility study done to evaluate the benefit of using PET/MRI with respect to improved identification of the target and hence target delineation

    Therapy plans are generated using image measures derived from standard radiotherapy plans or PET/MRI imaging. CT imaging is the standard imaging procedure used for radiotherapy treatment planning. In this clinical trial, a therapy plan will be generated from the initial PET/MRI imaging performed in the radiotherapy treatment position. This therapy plan will be compared with standard radiotherapy plans to evaluate the significance of using PET/MRI in radiotherapy treatment planning.

    Measured: Week 29 - Week 31 (1 - 2 weeks before surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study startMay 2027 (estimated)
  3. Primary completionMay 2030 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057831
Sponsor's protocol ID
IIT-0034
Status last verified
Oct 2026
First submitted
18 Aug 2023
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Total Neo-adjuvant Therapy and 18FDG-PET/MRI scan in people with Rectal Cancer, run by AHS Cancer Control Alberta.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kurian Joseph (780-432-8755, kurian.joseph@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint of the study is pathological response (pCR) prediction with PET/MRI. (time frame: Week 29 - Week 31). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06057831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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